The need to cover, restrain and protect the catheter and tubing site during medical treatment is well known. The catheter and tube needs to be protected from several adverse events. These events include catheter or tubing dislodgement causing infiltration of intravenous fluids as well as contamination from airborne sources that may lead to infections, disruption of a needed moisture barrier or preventing retrieval of fluids when suctioning is needed for medical treatments. The catheter or tubing site is at risk for unintended or purposeful dislodgement, which will interrupt the fluid administration or prevent fluid retrieval. This interruption will lead to delay of medical treatment, possible pain and infection in the patient, increased nursing time and higher medical costs due to the need to reinsert the catheter and/or tubing and due to the possibility of prolonged treatment time in hospital medical facility.
The prior art focuses on securing and protecting the intravenous area in the adult population. The prior art does not deal with the neonatal, pediatric, geriatric or other mammal population. In these populations, there is a higher risk of the patient grabbing, pulling or biting at the catheter and/or tubing resulting in dislodgment. Therefore, the prior art devices require improvements in order to solve the problems caused by use with all patients and in particular, in pediatric and geriatric patients.
A number of devices in the prior art disclose securing, protecting and allowing for visualization of the intravenous site. For example, in U.S. Pat. No. 4,669,458 to Abraham et al. and U.S. Pat. No. 6,809,230 to Hancock, a clear plastic window is adhesively applied to the IV site. U.S. Pat. No. 5,112,313 to Sallee and U.S. Pat. No. 5,116,324 to Brierley disclose a plastic cover over the IV site. These patents disclose nonflexible devices that allow the covering to be raised to allow inspection of the insertion site. Other patents such as U.S. Pat. No. 6,322,539 to Cook are intravenous guards shaped like animals to protect the IV site. They are held in place by a wristband. Other prior art patents are U.S. Pat. No. 503,973 to Lovejoy, U.S. Pat. No. 5,342,317 to Claywell and U.S. Pat. No. 6,228,064 to Abita. These patents disclose methods and apparatus for holding the intravenous catheter in place using a strap or band that may or may not be adhered to skin.
There are a number of disadvantages to each of the inventions in the prior art. The ability for the intravenous catheter to slide out of the venous or arterial lumen, thereby causing dislodgement and infiltration of fluids within the subcutaneous space leads to a caustic painful reaction and possible infection. Prior art issues also include lack of safety in the pediatric population, membranes that can be interrupted by tearing, and covers that do not anchor the intravenous catheter in place in a one-piece method. Therefore, there exists a need for a one-piece system and method of anchoring and protecting an intravenous catheter while also allowing for visual assessment of the intravenous catheter. The one-piece system should also be capable of covering other tubing devices, with slight modification, such as suctioning devices.